None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is a condition in which the upper airway of patients closes off during sleep. This leads to low levels of oxygen and multiple awakenings during the night. There are many factors contributing to the abnormal blockage of the upper airway including the shape, length and strength of the airway itself. Upper airway surgery can help influence these factors. However, there are still patients with residual sleep apnoea despite upper airway surgery. The aim of this study is to test the impact of oxygen therapy in patients with residual sleep apnoea following upper airway surgery. Oxygen therapy will lower the sensitivity of participants ventilator control system and is expected to help further improve their OSA. The study is intended to discover if the combination of oxygen therapy and upper airway surgery can completely resolve OSA in patients where surgery is not able to resolve OSA on its own. The study will involve each identified participant to undergo two sleep studies over two nights. These visits will tell us if the administration of oxygen therapy after upper airway surgery can completely resolve OSA in patients who still snore. All participants will receive one night without oxygen, and one night with oxygen, to be used as a direct comparison. Measurements of breathing pattern, heart beat, blood pressure, muscle activity, eye movements, brain activity and the level of oxygen in the blood in the blood will be recorded and later interpreted by investigators specialized in OSA. We believe that the combination of oxygen and upper airway surgery could positively impact patients OSA and their quality of life. It can potentially provide additional treatment options for sufferers of residual OSA despite surgical management.
Interventions
Oxygen therapy will be administered to patients as they sleep in the sleep laboratory at Monash Medical Centre.
100% Oxygen will be administered at a flow rate of 4L/min via nasal cannula.
The treatment will be administered by trial investigators who are sleep scientist/technicians employed by Monash Health and who are experienced in delivering oxygen to sleeping patients which they do as part of their routine work.
The Oxygen treatment will be delivered over a single night of sleep (typically 6
Oxygen therapy will be administered to patients as they sleep in the sleep laboratory at Monash Medical Centre. 100% Oxygen will be administered at a flow rate of 4L/min via nasal cannula. The treatment will be administered by trial investigators who are sleep scientist/technicians employed by Monash Health and who are experienced in delivering oxygen to sleeping patients which they do as part of their routine work. The Oxygen treatment will be delivered over a single night of sleep (typically 6-7hrs), i.e. one session. The control/placebo treatment will be Room Air delivered at a flow rate of 4L/min via nasal cannula. The control/placebo will be delivered continuously while patients sleep (typically 6-7hrs). Sleep studies will be conducted within one week of one another.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients will be selected from a cohort of patients suffering from obstructive sleep apnoea who have had upper airway surgery to treat their sleep apnoea but who have failed to respond to surgical treatment and who have ongoing sleep apnoea.
Exclusion criteria
Nil.
Outcome results
None listed